BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVANOVA USA, INC. SMART PERFUSION PACK

    MDR report key: 10244681 · Received July 7, 2020

    Report

    Report Number
    MW5095401
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 2, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    OXYGENATOR WAS PRIMED IN USUAL STERILE FASHION IN PREPARATION FOR NON-EMERGENT PROCEDURE. ITEM WAS FOUND TO BE LEAKING FROM THE TEMPERATURE PROBE PORT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706951 LIVANOVA USA, INC. SMART PERFUSION PACK TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA, INC. 047004501 2005800051

    Patients

    Seq Age Sex Outcome Treatment
    1